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Clinical Pharmacology
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Clinical Pharmacology

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Table 2 summarizes the mean pharmacokinetic parameters for unconjugated and conjugated estrogens and medroxyprogesterone acetate following administration of 2 PREMPRO 0.45 mg/1.5 mg and 2 PREMPRO 0.3 mg/1.5 mg tablets to healthy, postmenopausal women.

TABLE 2. PHARMACOKINETIC PARAMETERS FOR UNCONJUGATED AND CONJUGATED ESTROGENS (CE) AND MEDROXYPROGESTERONE ACETATE (MPA)

DRUG 2 x 0.3 mg CE/1.5 mg MPA Combination
(n = 30)		 2 x 0.45 mg CE/1.5 mg MPA Combination
(n = 61)
PK Parameter
Arithmetic
Mean (%CV)		 Cmax
(pg/mL)		 tmax
(h)		 t1/2
(h)		 AUC
(pg•h/mL)		 Cmax
(pg/mL)		 tmax
(h)		 t1/2
(h)		 AUC
(pg•h/mL)
Unconjugated Estrogens
Estrone 79
(35)		 9.4
(86)		 51.3
(30)		 5029
(45)		 91
(30)		 9.8
(47)		 48.9
(28)		 5786
(42)
BA* -Estrone 56
(46)		 9.4
(86)		 19.8
(39)		 1429
(49)		 67
(37)		 9.8
(47)		 21.5
(49)		 2042
(52)
Equilin 30
(43)		 7.9
(42)		 14.0
(75)		 590
(42)		 35
(40)		 8.5
(34)		 16.4
(49)		 825
(44)
PK Parameter
Arithmetic
Mean (%CV)		 Cmax
(ng/mL)		 tmax
(h)		 t1/2
(h)		 AUC
(ng•h/mL)		 Cmax
(ng/mL)		 tmax
(h)		 t1/2
(h)		 AUC
(ng•h/mL)
Conjugated Estrogens
Total Estrone 2.4
(38)		 7.1
(27)		 26.5
(33)		 62
(48)		 3.0
(37)		 8.2
(39)		 25.9
(23)		 78
(40)
BA* -Total Estrone 2.2
(36)		 7.1
(27)		 16.3
(32)		 41
(44)		 2.8
(36)		 8.2
(39)		 16.9
(36)		 56
(39)
Total Equilin 1.5
(47)		 5.5
(29)		 11.5
(24)		 22
(41)		 1.9
(42)		 7.2
(33)		 12.2
(25)		 31
(52)
PK Parameter
Arithmetic
Mean (%CV)		 Cmax
(ng/mL)		 tmax
(h)		 t1/2
(h)		 AUC
(ng•h/mL)		 Cmax
(ng/mL)		 tmax
(h)		 t1/2
(h)		 AUC
(ng•h/mL)
Medroxyprogesterone Acetate
MPA 1.2
(42)		 2.8
(61)		 42.3
(34)		 29.4
(30)		 1.2
(42)		 2.7
(52)		 47.2
(41)		 32.0
(36)
BA* = Baseline adjusted
Cmax = peak plasma concentration
t max = time peak concentration occurs
t1/2 = apparent terminal-phase disposition half-life (0.693/λz)
AUC = total area under the concentration-time curve

Brand Name: Prempro
Generic Name: Conjugated Estrogens, Medroxyprogesterone Acetate
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